QA Specialist – GMP, Deviation Investigations & Quality Ops

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Job summary

Amgen Ohio (AOH) seeks a Specialist QA to drive quality operations in the Final Drug Product plant. You will lead cross-functional teams, approve critical documents, and ensure GMP compliance while addressing deviations and CAPAs.

You will partner with Manufacturing, QC, Engineering, and Supply Chain to uphold record integrity, enable timely batch disposition, and support audits. The role emphasizes continuous improvement and adherence to safety and quality standards.

Qualifications

• Doctorate, or Master’s with 2 years QA/Manufacturing experience
• Bachelor’s with 4 years QA/Manufacturing experience
• Associates with 8 years QA/Manufacturing experience
• High school diploma with 10 years QA/Manufacturing experience
• Experience with GMP/GCP operations or regulated industry

Responsibilities

• Review and approve controlled documents (SOPs, validation docs)
• Provide quality oversight for quality records and deviations/CAPAs
• Lead investigations and deviations resolutions
• Ensure compliance with GMP requirements and records disposition
• Support audits and inspections by regulatory agencies
• Contribute to Lean Transformation and Operational Excellence initiatives

Skills

Quality oversight

Investigations

Regulatory inspections

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Tools

SOPs

Validation Protocols

Validation Reports

Electronic Master Batch Records

Job description

Amgen Ohio (AOH) seeks a Specialist QA to drive quality operations in the Final Drug Product plant. You will lead cross-functional teams, approve critical documents, and ensure GMP compliance while addressing deviations and CAPAs.

You will partner with Manufacturing, QC, Engineering, and Supply Chain to uphold record integrity, enable timely batch disposition, and support audits. The role emphasizes continuous improvement and adherence to safety and quality standards.